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news.Melbourne-based biotech firm Living Cell Technologies has filed a request to meet with the FDA to seek guidance on the development program of its NeurotrophinCell product before submitting an investigational new drug application.
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NeurotrophinCell (NtCell) is Living Cell’s injectable live cell product being developed for the treatment of patients with neurodegenerative diseases. NtCell is manufactured using natural porcine cells that are encased in a bio-polymer capsule developed from seaweed. The cells used are choroid plexus brain cells, which produce spinal cord fluid and a range of neurotrophins or growth factors, for the repair and function of the brain.
The biocapsules act as an immune barrier, allowing for the cocktail of hormones to leave the capsule, but preventing the body’s immune system from rejecting the cells. No immunosuppression is required in the treatment.
“Our goal is to make sure that we have addressed all of the requirements outlined in the FDA’s Guideline on Xenotransplantation Products and other relevant guidance,” said Mr David Collinson, Living Cell’s CEO.
Living Cell’s first targeted application of NtCell is Huntington’s disease; a devastating neurological disorder that currently has no cure or treatment. It is an inherited disease that progresses rapidly with dementia and progressive movement difficulties.